TWN
Info Service on Health Issues (Oct12/01)
22 October 2012
Third World Network

Dear
friends and colleagues,

Many
Asian countries are taking actions to promote cheaper medicines through
compulsory licensing, with Indonesia being the latest case when for
the third time a Presidential Decree was signed in exercise of “government
use” provisions under patent law, a form of compulsory licence. The
3 September Decree enables local manufacturers to make, import and
sell generic versions of seven patented drugs used for treating HIV-AIDS
and hepatitis B.

Below
is an article by Martin Khor, Executive Director of South Centre,
that provides more details as well as an overview of similar actions
in Asia staring with Malaysia in 2003.

The
attached table contains information on the most recent Indonesian
case.

With
best wishes,

Third
World Network.

Asian
countries act to get cheap drugs

by
Martin Khor

(first
published in The Star [Malaysia] dated 22 October 2012)

Recent
government actions by Indonesia and India to issue compulsory licenses
is extending the trend in Asia to increase access to cheaper medicines
to treat serious ailments, especially HIV/AIDS, cancer and hepatitis
B.

The
supply of generic medicines, either through import or local production,
has been the major method of reducing prices and making the drugs
affordable to more people.

When
the required medicines are patented, which usually results in high
prices, governments are allowed by the WTO rules to issue a compulsory
license to enable themselves or private companies to import or produce
generic versions, which usually cost much less.

In
2003, Malaysia became the first developing country to issue a compulsory
license to a local firm to import drugs to treat HIV-AIDS from India.
The cheaper generic drugs enabled the government to treat many more
patients within the same budget.

Following
this, Indonesia in 2004 issued a Presidential decree enabling the
production of a some HIV-AIDS drugs while Thailand in 2007 issued
compulsory licenses for several HIV-AIDS and cancer drugs.

In
March this year, India approved its first compulsory license enabling
a local company to produce a generic version of an anti-cancer drug,
which could reduce the price of treating kidney and liver cancer from
US$5,200 a month (the price of the branded product) to $160 a month
(the price of the generic product).

The
latest measure was taken on 3 September by Indonesian President Dr.
Susilo Bambang Yudhoyono who issued a decree which has the effect
of a compulsory license. It enables local manufacturers to make, import
and sell generic versions of seven patented drugs used for treating
HIV-AIDS and hepatitis B.

The
decree said that in line with the urgent need to control HIV/AIDS
and Hepatitis B in Indonesia, “it is necessary to continue and expand
the access policies to provide access to antiviral and anti-retroviral
medicines still protected by patent.”

This
is the third time Indonesia has issued a set of compulsory licenses.
The latest decree stated that the 2004 and 2007 decrees were no longer
sufficient to implement the policies.

The
compulsory license is aimed at significantly reducing the prices of
these life-saving medicines and making them accessible to thousands
more Indonesian patients.

According
to the decree, the generic companies would have to pay a royalty of
0.5% of the net sales value of the generic drugs to the companies
that own the patents, such as Merck, Glaxo SmithKline, Bristol Myers
Squibb, Abbott and Gilead.
"We will ensure the availability of good-quality, safe and effective
generic versions of anti-retroviral and anti-viral drugs," said
H.M, Subuh, infectious disease control director at the Indonesian
Health Ministry, as quoted in the Jakarta Post of 19 October.

The
first decree in 2004 enabled cheaper generic medicines that provided
HIV-infected patients with first-line anti-retroviral therapy. However,
these have become ineffective or less effective because of increasing
resistance or the lower safety of the drugs.

The
latest decree enables the supply of generic anti-retroviral products
for not only better first but also second-line anti-retroviral therapy.

"With
the 2012 regulation, we obviously can improve access to quality but
affordable drugs," Maura Linda Sitanggang, the Health Ministry's
Director General for Pharmaceuticals and Medical Equipment, told The
Jakarta Post. "We're using this mechanism concerning public interest
on the production of quality but affordable medicines to treat HIV
and HBV.”

The
seven medicines which are the subject of the compulsory license (known
in this case as for “government use”) are efavirenz, abacavir, didanosin,
lopinavir + ritonavir combination, tenofovir, tenofovir + emtricitabine,
and tenofovir + emtricitabine + efavirenz.

All
the drugs are used to treat HIV-AIDS. The drug tenofovir (brand name
Viread produced by patent holder Gilead) is also used to treat hepatitis
B, which affects 13 million people in Indonesia. It had been approved
in the United States for treating HIV-AIDS in 2001 and for treating
chronic Hepatitis B in 2008.

The
combination drug tenofovir + emtrisitabin (brand name Truvada, produced
by Abbot) is taken in a single dose once a day. It has been used to
treat HIV-AIDS and in July 2012 it also became the first drug approved
by the US Food and Drug Administration for use as a preventive measure,
to reduce the risk of HIV infection to people at high risk of infection
including those who may engage in sex with HIV infected patients.

The
Indonesian decree was the second compulsory license in Asia this year.

In
India, the Patent Office in March approved the country’s first compulsory
license to a local firm Natco Pharma to make a generic version of
the cancer drug sorofenib tosylate (brand name Nexavar, produced by
Bayer).

It
was argued that at the high price of 2.8 lakh rupees (US$5,200) for
a month’s dosage of Nexavar, only 200 patients were treated in India
in a year. Natco said that 8,000 people would need the drug, and it
could supply a generic version at 8,800 rupees (US$160) for a month’s
treatment.

The
drug is used to treat advanced kidney and liver cancer. According
to the terms of the license, Natco would pay Bayer royalties of 6%
of its net sales.

Bayer
challenged the compulsory license and on 16 September the Intellectual
Property Appellate Board rejected its petition, ruling that “If a
stay is granted it will jeopardise the interests of the public who
are in need of the drug.”

Other
developing regions have also been making use of the compulsory license
option in the WTO’s intellectual property treaty known as TRIPS. They
include Brazil and Ecuador in Latin America and Kenya, Zambia and
Zimbabwe in Africa.

In
2001, the WTO’s Ministerial Conference in Doha adopted a TRIPS and
Public Health Declaration that asserted that the TRIPS Agreement does
not and should not prevent Members from taking measures to protect
public health.

It
affirmed that the Agreement should be interpreted in a manner supportive
of the right to health and access to medicines for all.

The
Declaration clarified: “In this connection, we reaffirm the right
of WTO Members to use, to the full, the provisions in the TRIPS Agreement,
which provide flexibility for this purpose.”